Zdrowie i gospodarka · 14/05/1998

Guidance for Industry on Classifying Resubmissions in Response to Action Letters; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Classifying Resubmissions in Response to Action Letters.'' This guidance explains how the agency will classify resubmissions of new drug applications (NDA's) and license applications (LA's) and specifies the agency's response timeframes. The guidance also recommends procedures for making resubmissions. DATES: Written comments may be submitted on the guidance by August 12, 1998. General comments on the agency guidance documents are welcome at any time. ADDRESSES: Copies of this guidance for industry are available on the Internet at http://www.fda.gov/cder/guidance/index.htm, or http:// www.fda.gov/cber/guidelines.htm. Submit written comments on this guidance to the Dockets Management Branch (HFD-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. Comments are to be identified with the docket number found in brackets in the heading of this document. After the comment period, comments may be submitted to one of the centers at the address below.